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The role of competent authorities in Bio Vigilance

M. Jesus Felix (mjfelix@catsalut.cat)Medical Coordinator of Tissues and Cells

Catalan Transplant Organization on behalf of Catalan Health Services .

Health Department. Government of Catalonia

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SURVEILLANCE(BIO VIGILANCE)

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Catalonian reporting circuit

Urgentevents:

before 24 h

Non urgent events:

before 36 h

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Reporting Circuit

CatalonianHospitals

Other SpanishHospitals

EuropeanHospitals

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SAR in recipients

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SAR in living donor

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Incident

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SAE

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Serious adverse effect: affects the product and /or

the process

Serious adverse reaction: affects the person (the donor

or the recipient)

DEFINITIONS

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Evaluation of the event

Case investigation Risk evaluation

Notification: Clinical Report

Corrective implementing measures if required

Solving the case to prevent and register it

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The role of Competent authorities (CA)

Clinical notification report sent to CA

Analyzing

and investigating

Ask for more /new data (if necessary)

To TE To Transplant Responsible

Donor data Tissue data

Contralateral cornea : Transplanted and results

or not transplanted. Wy?

- SAE/SAR explanation - Intervention data

- First measures applied -Recipient status

- Consequences for recipient

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Implementing Measures

• With all data and documents available, it becomes:

An evaluation of possible damage is made

Appropriate measures are taken

Disseminating information to all involved areas

and responsible

Close the case

And introduced SAE/SAR in BV Register

An evaluation of possible damage is made

Appropriate measures are taken

Disseminating information to all involved areas

and responsible

Close the case

And introduced SAE/SAR in BV Register

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CLINICAL CASES

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Avaluation of an Event

• Every event should be analyzed in: – Severity.– Imputability.– Impact.

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Severity

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Imputability

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Impact Assessment• Step 1: assessing likelihood of occurrence/

recurrence of SAR/E:

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Impact Assessment• Step 2: assessing Impact /Consequences of

SAR/E should it recur.

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Impact Assessment• Step 3: Applying the Impact Matrix.

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Impact Assessment• Step 4:• The response of a tissue or cell bank or a health authority to a specific

SAE/SAR should be proportionate to the potential impact as assessed by the matrix described.

• GREEN: The tissue or cell bank to manage the corrective and preventive actions and the health authority to file the report and keep a ‘watching brief’.

• YELLOW: Requires interaction between the tissue or cell bank and the health authority which may request an inspection that focuses on the SAE/SAR and corrective and preventive actions to be followed up, including evidence of effective recall, where necessary. Written communication to professionals working in the field might be appropriate.

• RED: Health authority will generally designate representatives to participate in developing or approving the corrective and preventive action plan, possibly a task force to address broader implications. Inspection, follow up and written comm

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MADE-UP EXAMPLE

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• A cornea recipient from United Kingdom developed vCJD symptoms five years after the graft. SAE or SAR??

• Do you need to measure severity and imputability?

• And the impact assessment tool?

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• A cornea recipient from United Kingdom developed CJD symtomes five years after the graft. SAE or SAR?? SAR

• Do you need to measure severity and imputabilily? YES

• And the impact assessment tool? YES

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Severity

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Imputability

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Impact Assessment• Step 1: assessing likelihood of occurrence/

recurrence of SAR/E:

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Impact Assessment• Step 2: assessing Impact /Consequences of

SAR/E should it recur.

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Impact Assessment• Step 3: Applying the Impact Matrix.

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CASE 1

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• A piece of bone identified as distal femur was sent to a hospital to be grafted. When the professionals opened the graft they discovered it was a proximal femur.

• What would you do?

• Is it a SAE or SAR?

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• The tissue was grafted without any complication for the recipient.

• The label and package procedure of the tissue establishment was revised.

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CASE 2

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• Donor of heart valves and corneas. The first determination RPR was negative. But in a second determination, it was TPHA + (IgG +, IgM-). One cornea was already grafted.

• What would you do?

• SAE or SAR?

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• Another analysis was performed, and it was also positive.

• It was a past infection.

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• The corneas were kept in Optisol®

• No complication in the recipient.

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CASE 3

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• An haematologist reported a neumothorax while setting a central catheter in the subclavian for obtaining peripheral blood for an autologous HSCT.

• What would you do?

• SAE or SAR?

• Can the event be imputed to the procedure?

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• The patient stayed in hospital where he received medical treatment and he recovered completely. The transplant was performed.

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CASE 4

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• Two tissue recipients presented a positive culture to Enterobacter cloacae in the exudate of the surgical wound.

• What would you do?

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• In both cases the antiobiogramme was the same, and it was sensible to Gentamicina (an antibiotic used for cleaning the bones at the tissue bank).

• In one recipient the tissue culture was negative but the site culture wasn’t performed.

• In the other recipient no culture was performed.

• What else would you do?? SAE or SAR?

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• They contacted the other professionals that had grafted tissues from the same donor. The cultures in all cases were negative.

• A bone piece stayed at the tissue establishment and it was sent to be analyzed. The result was also negative.

• They concluded that it was a surgery contamination.

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• They concluded that it was a surgery contamination.

• Both recipients got antibiotic treatment and they recovered completely.

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CASE 5

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• The results of the anatomical pathology informed that a tissue donor had an adenocarcinoma.

• It was a heart valve and ocular donor.

• One cornea was grafted, the other was discarded due to quality reasons. Heart valves were stored at the bank.

• What would you do? SAE or SAR?

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• Follow up of the recipient. He hasn’t developed any reaction.

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CLINICAL CASES